Pharma Initiative Support

Regulatory Authorities have been accepted Global simultaneous development and global clinical data to bring innovative pharmaceuticals to patients in Japan since 2007. Regulatory Authorities have changed regulations to accelerate pharmaceuticals development in Japan, for instance acceleration of drug review period, Sakigake designation, Conditional approval and so on. Regulatory environment of pharmaceuticals in Japan is significantly changed and be complexed.
Pharma Initiatives Supports helps innovative product development through providing clinical development expertise and regulatory expertise in Japan toward successful commercialization in Japan. In detail, Pharma Initiative Support reviews all relevant data including non-clinical data and provides clinical development strategies and plan after gap analyses. Pharma Initiative Support also supports negotiations with regulatory authorities including PMDA, for instance PMDA consultations, Orphan Drug Designation(ODD), Sakigake Designations. We support an execution of Global clinical studies. We also support Japan-NDA and successful regulatory approvals.

Support Product Development Strategy and Implement plan driven by Japan　Regulatory Requirement.

Support document preparation and execution for regulatory related activities, Pharmaceuticals, Medical Devices and Agency (PMDA)
consultation, Orphan Drug Designation (ODD), Sakigake Designation, Clinical Trial Notification (CTN) and CMC related submission.

Support translation of regulatory related documents.

Service as the primary point of contact with Regulatory Authorities, Ministry of Health, Labor and Welfare and PMDA on behalf of clients.

Support all communications with Regulatory authorities, MHLW, PMDA and so on.

Identify and Manage Key Opinion Leaders (KOL) in targeted therapeutic areas on behalf of pharmaceuticals.

Support Design and implement of product development.

Support selection and management of CRO for implementation of product development.

Serve liaison for clients to oversee and manage execution of product development plan through CROs.

Support New Drug Application in Japan (J-NDA) including CTD preparation, eCTD publishing, Negotiation with PMDA and so on.

Support recruitment through introduction of talented people

Clinical development strategy and planning

Regulatory strategy planning and regulatory document development

Execution of Clinical development in Japan

Management of clinical study in Japan

KOL Management

Project Management

CRO management

Risk Management planning

Proactive problem solving

vCommunication in both Japanese and English